Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

University Hospital Ostrava140 enrolled

Overview

The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on cardiac index trending by transesophageal Dopplerometry would result in reduced complications and reduced length of hospital stay in major abdominal surgery patients, when compared to patients treated with press treatment algorithm.

Despite standardisation of intraoperative care provided for risk surgery patients, the preoperative mortality remains higher than expected. The aim of the goal-directed heamodynamic therapy (GDT) is to improve the altered cardiovascular function and to reach the desired intraoperative values of oxygen supply (DO2) and cardiac index (CI). Standard haemodynamic measurements, such as heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) remain relatively unchanged despite reduced blood flow. However, GTD is able to detect early hypo perfusion abnormalities. The aim of goal-directed heamodynamic therapy, based on the titration of fluids and vasoactive drugs to physiological flow-related end points is to reduce perioperative complications, perioperative morbidity and mortality. We hypothesise, that following this treatment regimen results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secondary endpoint).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Major Abdominal Surgery Duodenohemipancreatectomy Rectal Resection Extensive Bowel Surgery

Interventions

Flow groupPROCEDURE

After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.

Press groupPROCEDURE

After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 21 years of age and above * anticipated duration of surgery more than 120 minutes * estimated blood loss exceeding more than 15% of blood volume * American Society of Anesthesiology (ASA) classification 2 or 3 * indication for an arterial line and central venous catheter Exclusion Criteria: * pregnant or lactating women * age below 21 years of age * emergency surgery * American Society of Anesthesiology (ASA) classification 1 * sepsis and septic shock * severe cardiac arrhythmias * patients with pathology or intervention on oesophagus

Locations (1)

University Hospital Ostrava

Ostrava, Czechia

Outcomes

Primary Outcomes

Pre-defined postoperative complications for up to 28 days after surgery

The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

Time frame: 24 months

Secondary Outcomes

The length of hospitalization

Length of hospital stay will be obtained from the patient record.

Time frame: 24 months

Data from ClinicalTrials.gov

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